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FDA 510(k) Application Details - K082132
Device Classification Name
Unit, Phacofragmentation
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510(K) Number
K082132
Device Name
Unit, Phacofragmentation
Applicant
BAUSCH & LOMB, INC
1400 North Goodman Street
Rochester, NY 14609 US
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NED LUCE
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Regulation Number
886.4670
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Classification Product Code
HQC
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Date Received
07/29/2008
Decision Date
08/28/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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